Global Study Manager

7 months ago

Mississauga, Canada AstraZeneca Full time

This is a 12-month contract.

The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Director (GSD) or Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model, AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

**Accountabilities**:

- In partnership with AZ team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery.
- Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).
- Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
- Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
- Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
- Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
- Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
- Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
- Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
- Supports GSD and/or GSAD with overall project management as per agreed delegation.
- For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g., description of services and transfer of obligations)
- Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

**Education, Qualifications, Skills and Experience**
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
- Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
- Knowledge of clinical development / drug development process in various phases of development and therapy areas
- Excellent knowledge of international guidelines ICH/GCP
- Excellent communication and relationship building skills, including external service provider management skills
- Good project management skills
- Demonstrated ability to collaborate as well as work independently
- Demonstrated leadership skills
- Computer proficiency, advanced computer skills in day-to-day tasks
- Excellent verbal and written communication in English

**Desirable Experience**
- Advanced degree
- Experience in all phases of a clinical study lifecycle
- Basic knowledge of GXP outside of GCP (i.e GMP/GLP)

  • Global Study Manager

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Short role description**: The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report...

  • Global Study Manager

    2 months ago

    Mississauga, Canada AstraZeneca Full time

    The GSM is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSM works cross-functionally with internal...

  • Global Study Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study...

  • Global Study Director

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Exciting Opportunity in Mississauga, Canada: Join Our Team as a Global Study Director (GSD)** Are you ready to play a pivotal role in shaping the future of clinical research? We are seeking a dynamic Global Study Director to lead the planning and delivery of high-priority and complex clinical studies within our BioPharmaceuticals Clinical Operations team....

  • Global Study Manager

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, 12 Month Contract** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing...

  • Global Study Associate, Haematology

    2 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, Haematology (12 month contract)** **Mississauga, Canada (hybrid work - average of 3 days in office)** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and...

  • Global Study Director Biopharmaceuticals

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Locations**: **Barcelona, Spain (on-site)** **Warsaw, Poland (on-site)** **Mississauga, Canada (on-site)*** The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or...

  • Global Study Manager, R&i

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, R&I** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow...

  • Global Study Director BioPharmaceuticals

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    Locations: Barcelona, Spain (on-site) Warsaw, Poland (on-site) Mississauga, Canada (on-site) The Global Study Director (GSD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple...

  • Global Study Associate Director

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director** **Hybrid Work - 3 days/week from our Mississauga office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the...

  • Global Study Associate

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing...

  • Global Study Manager, Haematology

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Haematology (CAR-T Program)** **12 Month Contract** **Hybrid Work - 3 days/week from Mississauga office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions...

  • Global Study Associate Director, Respiratory and

    4 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director, Respiratory and Immunology** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation -...

  • Global Study Associate

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    This is a 12-month contract. The Global Study Associate is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The...

  • Study Manager

    2 months ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Oct 15 2024 **Job Purpose**: - Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - SM role was implemented to have a broader...

  • Study Manager

    1 month ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Nov 23 2024 **Job Purpose**: - Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - SM role was implemented to have a broader...

  • Global Study Associate Director, Respiratory and

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate Director, Respiratory and Immunology** **Hybrid Work - 3 days/week from our Mississauga office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even...

  • Global Study Manager, Oncology

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Manager, Oncology** **6 Month Contract** **Hybrid Work - 3 days/week from Mississauga office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the...

  • Global Study Associate, Smo

    3 weeks ago

    Mississauga, Canada AstraZeneca Full time

    **Global Study Associate, SMO** **12 Month Contract** **Hybrid Work - on average 3 days/week from office** **Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office** At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately...

  • Study Manager

    3 weeks ago

    Mississauga, Canada GSK Full time

    Site Name: Mississauga Milverton Drive Posted Date: Nov 23 2024 Job Purpose: Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. SM role was implemented to have a broader impact on...